NEWS - FDA calls for strong warnings on all NSAIDs including Celebrex

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FDA calls for strong warnings on all NSAIDs including celecoxib

Rheumawire

Apr 7, 2005

Gandey

Rockville, MD - Today the US Food and Drug Administration recommended new

boxed warnings and medication guides for most nonsteroidal anti-inflammatory

drugs (NSAIDs) to highlight the potential for increased cardiovascular risks

and gastrointestinal bleeding. The agency made special mention of Pfizer's

blockbuster celecoxib (Celebrex), advising clinicians to prescribe the

lowest effective dose and urging the company to commit to long-term study to

address the safety of celecoxib compared with naproxen and others.

" Today's actions protect and advance the health of the millions of Americans

who rely on these drugs every day, " Dr Galson, acting director of the

FDA's Center for Drug Evaluation and Research, told the press.

Pfizer, already reeling over urgings by international regulators to remove

valdecoxib (Bextra) from the market, said it would work with the FDA on its

new recommendations. " Pfizer and the FDA plan further discussions regarding

the precise content of the Celebrex label, " the company said in a statement.

" Pfizer has accumulated extensive Celebrex clinical data over the past 10

years involving more than 40 000 patients. " The company said that it would

conduct additional long-term clinical studies evaluating the benefits and

risks of celecoxib and that it would work closely with the FDA to develop an

additional medication guide to assist healthcare professionals and patients.

" In reaching these decisions, the FDA has carefully considered the available

data on all of the NSAIDs, " the agency said in a news release, pointing out

that considerations included presentations, discussions, and votes from the

advisory committees deliberating this past February over the benefits and

risks of these products. The FDA says it will work closely with

manufacturers to ensure that all requests are quickly put into action.

***********

Recommendations for celecoxib

Include boxed warning alerting of cardiovascular and gastrointestinal risk.

Contraindicate for use in patients who have recently undergone coronary

artery bypass surgery.

Encourage prescribers to discuss with patients the potential benefits and

risks of celecoxib and other treatment options.

Encourage the use of the lowest effective dose for the shortest duration

consistent with individual patient treatment goals.

Include new medication guide as part of product labeling, further informing

patients.

Promote additional long-term study to address safety of celecoxib compared

with naproxen and other appropriate drugs.

***********

Recommendations for prescription NSAIDs

Include boxed warning alerting of cardiovascular and gastrointestinal risk.

Contraindicate for use in patients who have recently undergone coronary

artery bypass surgery.

Encourage the use of the lowest effective dose for the shortest duration

consistent with individual patient treatment goals.

Include new medication guide as part of product labeling, further informing

patients.

Conduct and submit a review of available controlled clinical-trial

databases.

***********

Recommendations for over-the-counter NSAIDs

Include boxed warning alerting of cardiovascular and gastrointestinal risk

for all products containing ibuprofen, naproxen, and ketoprofen.

Offer specific instructions about which patients should seek the advice of a

physician before using these drugs.

Incorporate stronger reminders about limiting the dose and duration of

treatment.

Issue warnings about potential skin reactions.

***********

The FDA points out that long-term controlled clinical trials have not been

conducted with most NSAIDs. " However, " the agency says, " the available data

suggest that use of these drugs may increase CV risk. It is very difficult

to draw conclusions about the relative CV risk among the COX-2 selective and

nonselective NSAIDs with the data available. " As a result, the FDA says it

will work with sponsors and other stakeholders such as the National

Institutes of Health to encourage additional long-term controlled clinical

trials of nonselective NSAIDs to further evaluate the potential for

increased risk.

The FDA says it will continue to notify healthcare providers and patients in

a timely fashion as new information becomes available. In the meantime, the

agency urges clinicians and patients to report adverse-event information to

the MedWatch program by telephone (1-800-FDA-1088), fax (1-800-FDA-0178), or

online.

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org